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Alexion ups guidance

March 11, 2014 12:50 AM UTC

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) raised its 2014 guidance after reaching an agreement with the French government over reimbursement for Orphan drug Soliris eculizumab. The company is not disclosing details of the agreement or the list price of Soliris in France, but said the agreement covers both atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH) -- the drug's two approved indications. Alexion said the agreement also covers Soliris shipments prior to 2014, and as a result the company expects to record about $88 million in additional Soliris sales in 1Q14. Alexion said it now expects 2014 non-GAAP EPS of $4.37-$4.47 on full-year revenues of $2.15-$2.17 billion. In January, the company said it expected 2014 EPS of $3.70-$3.80 on $2-$2.02 billion in revenues.

The French reimbursement agreement comes less than a week after the U.K.'s NICE requested information from Alexion on the development costs for Soliris for aHUS, as well as an explanation of how those costs relate to the company's proposed price for Soliris for the indication. In the U.K., Soliris costs L3,150 ($5,266) per vial, which translates to an estimated cost of L252,000-L340,200 ($421,243-$568,678) per patient for the first year of treatment, depending on the indication. A maintenance dose is estimated to cost L245,700-L327,600 ($410,712-547,616) per year (see BioCentury Extra, March 3). ...